This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Statistical Programming based in the United States.
This senior-level role is central to the delivery of high-quality statistical programming outputs that support global clinical development and regulatory submissions. You will lead and oversee programming activities that generate analysis datasets, tables, listings, and figures used in clinical study reports and integrated summaries. The position requires deep expertise in clinical trial reporting processes, regulatory standards, and advanced statistical programming within a highly regulated biopharmaceutical environment. You will collaborate closely with clinical development teams, biostatistics, and cross-functional stakeholders to ensure timely and accurate deliverables. The role involves both strategic oversight and hands-on technical leadership across complex, time-sensitive studies. You will also contribute to process improvements, resource planning, and harmonization of programming standards across therapeutic areas. This is a high-impact position where your work directly supports regulatory approvals and the advancement of life-changing therapies.
Accountabilities:
- Lead and oversee statistical programming activities for clinical studies, ensuring timely and high-quality deliverables.
- Develop and/or supervise the creation of analysis datasets, tables, listings, and figures for clinical trial reporting and regulatory submissions.
- Collaborate with Clinical Development, Biostatistics, and cross-functional teams to align on study deliverables and timelines.
- Ensure programming outputs and documentation comply with internal standards, regulatory requirements, and industry best practices.
- Design, review, and validate analysis files and programming specifications for clinical data reporting.
- Support regulatory submission activities, including integrated analyses, filings, and responses to health authority queries (FDA, PMDA, etc.).
- Anticipate resource needs and manage workload prioritization across multiple concurrent projects.
- Drive process improvements and harmonization of statistical programming practices across therapeutic areas.
- Provide technical leadership and mentorship to programming team members.
- Resolve complex programming, data, and reporting issues in time-sensitive environments.
Requirements:
- Bachelor’s, Master’s, or PhD in Biostatistics, Computer Science, or a related quantitative field, with relevant pharmaceutical/biotech experience (3–10+ years depending on degree).
- Extensive experience in statistical programming within pharmaceutical or CRO environments.
- Strong hands-on expertise with SAS programming, including macros and advanced analytics.
- Deep understanding of clinical trial design, analysis, and regulatory submission requirements (FDA, PMDA, ICH, GCP).
- Advanced knowledge of CDISC standards (SDTM, ADaM, CDASH).
- Proven experience supporting regulatory submissions, integrated analyses, and post-submission activities.
- Strong ability to manage multiple complex, time-sensitive projects simultaneously.
- Excellent communication, collaboration, and stakeholder management skills.
- Strong problem-solving skills with the ability to resolve technical and operational issues independently.
- Experience in oncology, virology, hematology, or inflammation therapeutic areas is highly desirable.
- Demonstrated leadership in driving programming standards and strategic initiatives.
Benefits:
- Competitive annual salary range of approximately $177,905 to $230,230 depending on experience and location.
- Eligibility for annual discretionary bonus and long-term incentive programs.
- Comprehensive healthcare coverage including medical, dental, vision, and life insurance.
- Paid time off, holidays, and flexible work arrangements (remote eligible).
- Retirement savings plan with additional employer-supported benefits.
- Opportunity to contribute to global regulatory submissions and life-changing therapies.
- Professional growth within a highly specialized, science-driven environment.
- Exposure to advanced clinical development and global regulatory processes.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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